8 September 2025 - After aducanumab’s accelerated approval for Alzheimer's disease, and prompted by long standing concerns regarding the accelerated approval pathway of the FDA, the FDA released guidance in December 2024 and January 2025 governing accelerated approval. 

Accelerated approval expedites medical product access through surrogate outcomes, or measures that are likely to, but have not been proven to, predict clinical benefit; sponsors are required to complete confirmatory trials after approval to verify benefit. This guidance includes information regarding what constitutes an appropriate surrogate, evidentiary standards, confirmatory trial fulfillments, and the withdrawal process for products that fail such trials.

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